Injectable Multiple Sclerosis Drug Passes EMA Regulatory Review

The European Medicines Agency (EMA) has recommended Biogen and AbbVie’s injectable multiple sclerosis drug for marketing approval. The drug – a monoclonal antibody called Zinbryta (daclizumab) – could be a new treatment option for patients with relapsing forms of the autoimmune disorder.

Compared to Biogen’s existing multiple sclerosis treatment, Avonex, Zinbryta reduced the annualized relapse rates (AAR) in patients with multiple sclerosis, in two Phase III clinical trials. The drug was also able to decrease the risk of 24-week disability progression, compared to Avonex.

Zinbryta works by binding to the IL-2 receptor on T-cells, which helps to reduce the immune system’s attack on the body’s central nervous system. Regulatory authorities in the US, Canada, Australia and Switzerland, are also reviewing the drug for approval.

“For people with relapsing forms of multiple sclerosis and active disease, Zinbryta has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Dr. Alfred Sandrock, executive vice president and chief medical officer at Biogen. “Zinbryta may offer another option for people with multiple sclerosis with its targeted mechanism of action which did not cause broad and prolonged immune cell depletion.”

The first drug to both slow the progression of relapsing multiple sclerosis and reduce the AAR, Biogen’s Avonex (interferon beta-1a) received US Food and Drug Administration (FDA) approval in 1996. Since then, the drug has held considerable market share, despite the availability of newer oral-dosage multiple sclerosis drugs like Biogen’s Tecfidera (dimehtyl fumarate).

Biogen and AbbVie are jointly developing Zinbryta. The drug is administered via a once-a-month subcutaneous injection, which is a convenient upgrade from Avonex’s daily intramuscular injection administration.

Biogen has been facing considerable heat lately over its direct-to-consumer (DTC) ad for Tecfidera. While some patients appreciated that the TV commercial was raising awareness for relapsing multiple sclerosis, others felt that it portrayed an unrealistic view of how active someone with the disease can be. After airing the ad since October of 2015, Biogen has now decided to pull the spot, and see whether the campaign has translated into higher revenues.